TOKYO – May 24, 2018 – Astellas Pharma Inc. (President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the post-marketing MATCH study exploring use of mirabegron versus placebo in men with overactive bladder (OAB) also taking tamsulosin for benign prostatic hyperplasia (BPH) met its primary endpoint of reducing the mean number of micturitions / 24 hours. In the study, the addition of mirabegron was well-tolerated and demonstrated superior improvement in quality of life (QoL). The data were presented at the 2018 Annual Meeting of the American Urological Association held in San Francisco.
“Through my past experiences of treating the condition, I had the impression that adding mirabegron to tamsulosin was a useful treatment. However, there was no evidence,” said Professor Hidehiro Kakizaki, Department of Renal and Urologic Surgery, Asahikawa Medical University, who presented the study results. “Therefore, it is very significant that the MATCH study, a randomized, placebo-controlled double blind study, recently proved it. I am also pleased that such evidence was obtained in Japan, where mirabegron was first commercialized. This treatment method is expected to serve as a useful treatment option for male patients with OAB symptoms following administration of tamsulosin.”
Assessed by ANCOVA (analysis of covariance), the adjusted mean change in micturitions / 24 hours from baseline to end of treatment was –1.27 in the mirabegron group vs. –0.75 for placebo, with a statistically significant adjusted mean difference between groups (–0.52; P<0.001). Mirabegron also showed superior efficacy to placebo for increase in mean volume voided (MVV) / micturition and change in overactive bladder symptom score (OABSS) total score. Differences between mirabegron and placebo groups were not statistically significant for urgency, urgency incontinence, incontinence and nocturia episodes. For QoL, mirabegron 50 mg group demonstrated statistically significant greater improvements from baseline to the end of treatment compared with placebo group in symptom bother score by OAB-q and total health-related QoL score by OAB-q. Overall, 23.4% of mirabegron vs. 22.5% of placebo patients reported ≥1 treatment-emergent adverse event (TEAE). There were no significant differences in both groups for major safety concerns regarding urinary retention or cardiovascular events.